This article is more than 5 years old. Information may no longer be current.
Percutaneous pulmonary valve implantation safe in patients with congenital heart defects
A heart valve used during percutaneous pulmonary valve implantation was safe and feasible in patients with congenital heart defects, according to a study published in EuroIntervention.
Sebastien Hascoet, MD, pediatric cardiologist in the department of congenital heart diseases at the Hospital Marie Lannelongue in Le Plessis-Robinson, France, and colleagues analyzed data from 82 patients (mean age, 27 years; 60% men) from the Pulmonic S3 registry who underwent percutaneous pulmonary valve implantation with a transcatheter heart valve (Sapien 3, Edwards Lifesciences).
Safety outcomes of interest included valve dislocation requiring surgical intervention, rates of periprocedural technical complications and periprocedural adverse events.
Among the cohort, 58.5% had tetralogy of Fallot and 16% had a native right ventricular outflow tract. Most patients (90.2%) received pre-stenting.
One patient had prosthesis dislodgement and another had conduit perforation. Both issues were resolved without open surgery.
Peak systolic gradient over the right ventricular outflow tract decreased from 46.3 mm Hg to 17.2 mm Hg. In addition, moderate to severe pulmonary regurgitation decreased from 86.3% to 0% and the number of patients with NYHA class II or higher decreased from 86% to 15.2%.
During a median follow-up of 201 days, two patients had valve thrombosis, which was resolved through anticoagulation. Other procedural complications, stent fracture, endocarditis or death were not reported within 2 years.
“The procedure results in good short-term hemodynamic and functional outcomes with very few adverse events,” Hascoet and colleagues wrote. “However, the endurance of such positive safety and efficacy outcomes remains to be demonstrated over the longer term, as does device durability. Nevertheless, the present study paves the way for more liberal implantation of the S3 valve in the pulmonic position.” – by Darlene Dobkowski
Disclosures: The study was supported by Edwards Lifesciences. Hascoet reports he received research funding, consultant fees and/or lecture honoraria from Edwards Lifesciences. Please see the study for all other authors’ relevant financial disclosures.